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510(k) K081485

SOMNOWATCH by Somnomedics GmbH — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2008
Date Received
May 28, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Somnomedics GmbH

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  • K201054 — SOMNOscreen plus (August 12, 2020)
  • K140861 — SOMNOTOUCH RESP (January 30, 2015)
  • K071556 — SOMNOSCREEN EEG10-20 (July 18, 2007)

Other clearances for product code MNR

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  • K243220 — Onera STS 2 (ONERA STS 2) (July 3, 2025)
  • K242224 — Happy Health Home Sleep Test (June 18, 2025)
  • K243092 — AcuPebble Ox (200) (March 19, 2025)
  • K243268 — TipTraQ (TTQ001) (February 3, 2025)
  • K244027 — SANSA HSAT (January 28, 2025)
  • K242290 — DormoTech NLab (January 8, 2025)